Sexually Transmitted Infections Among African American Women Who Have Sex With Women (WSW)

• ClinicalTrials.gov Identifier: NCT01043081
• Recruitment Status: Completed
• First Posted: January 6, 2010
• Last Update Posted: May 11, 2016
• Sponsor: University of Mississippi Medical Center
• Collaborators: Mississippi State Department of Health; University of Alabama at Birmingham
• Information provided by (Responsible Party): Leandro A. Mena, University of Mississippi Medical Center

Tracking Information

• First Submitted Date: January 4, 2010
• First Posted Date: January 6, 2010
• Last Update Posted Date: May 11, 2016
• Study Start Date: February 2009
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 4, 2010): Prevalence rates of sexually transmitted infections [ Time Frame: 18 Months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 4, 2010): Associated sexual risk behaviors [ Time Frame: 18 Months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sexually Transmitted Infections Among African American Women Who Have Sex With Women
• Official Title: Prevalence Rates of Sexually Transmitted Infections and Sexual Risk Behaviors Among African American Women Who Have Sex With Women
• Brief Summary: The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

Detailed Description

Historically, women who have sex with women (WSW) have been thought to be at low risk for acquiring sexually transmitted infections (STI), presumably due to the absence of genital mucosal contact present during vaginal-penile sex or due to the assumption that the vaginal mucosa experiences a lesser degree of trauma during female sex than during heterosexual sex. This assumption has been challenged and debated over the past two decades. In addition, the sexual health risks of WSW are only beginning to be understood.

To date the majority of research regarding STI in women has occurred in heterosexuals. National and local surveillance data that estimate the risk for STI transmission between WSW are limited, especially among African Americans. This is a group of women that may exhibit distinctive behavioral characteristics that may put them at higher risk for sexually transmitted infections STI and HIV than their Caucasian counterparts. This group of women has traditionally been reluctant to discuss their sexual orientation with physicians for fear of being stigmatized. The burden of STIs, including HIV, experienced by this group of women is largely unknown.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Endocervical and vaginal secretion specimens are being retained for future research studies in this field of sexually transmitted diseases.

• Sampling Method: Non-Probability Sample
• Study Population: The study population is African American women, aged 18 or above, who present to the Crossroads Clinic (STD Clinic) in the Jackson, MS metropolitan area for STI screening/evaluation who have engaged in sexual contact with another woman within the past 6 months.

Condition

• Sexually Transmitted Infections
• HIV Infections

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Muzny CA, Sunesara IR, Griswold ME, Kumar R, Lefkowitz EJ, Mena LA, Schwebke JR, Martin DH, Swiatlo E. Association between BVAB1 and high Nugent scores among women with bacterial vaginosis. Diagn Microbiol Infect Dis. 2014 Dec;80(4):321-3. doi: 10.1016/j.diagmicrobio.2014.09.008. Epub 2014 Sep 16.
• Muzny CA, Rivers CA, Parker CJ, Mena LA, Austin EL, Schwebke JR. Lack of evidence for sexual transmission of genital Candida species among women who have sex with women: a mixed methods study. Sex Transm Infect. 2014 Mar;90(2):165-70. doi: 10.1136/sextrans-2013-051361. Epub 2014 Jan 15.
• Muzny CA, Sunesara IR, Kumar R, Mena LA, Griswold ME, Martin DH, Lefkowitz EJ, Schwebke JR, Swiatlo E. Characterization of the vaginal microbiota among sexual risk behavior groups of women with bacterial vaginosis. PLoS One. 2013 Nov 13;8(11):e80254. doi: 10.1371/journal.pone.0080254. eCollection 2013. Erratum In: PLoS One. 2013;8(12). doi:10.1371/annotation/f7674ab1-fbd5-4293-ad2c-d1a795962e8b. Swiatlo, Edwin [added].
• Muzny CA, Sunesara IR, Austin EL, Mena LA, Schwebke JR. Bacterial vaginosis among African American women who have sex with women. Sex Transm Dis. 2013 Sep;40(9):751-5. doi: 10.1097/OLQ.0000000000000004.
• Muzny CA, Sunesara IR, Martin DH, Mena LA. Sexually transmitted infections and risk behaviors among African American women who have sex with women: does sex with men make a difference? Sex Transm Dis. 2011 Dec;38(12):1118-25. doi: 10.1097/OLQ.0b013e31822e6179.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 4, 2010): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Female
• Age 18 years or older
• African American race
• Sexual contact with another female within the past 6 months
• Ability to give written informed consent

Exclusion Criteria:

• Male
• Age less than 18 years old
• Race other than African American
• No sexual contact with another woman within the past 6 months
• Pregnant
• Prior enrollment in this study
• Participants who, for any reason, in the opinion of the investigator, do not have the ability to give written informed consent or may not be expected to comply with the requirements of the protocol

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01043081
• Other Study ID Numbers: 2008-0143
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Data will only be shared with investigators

• Current Responsible Party: Leandro A. Mena, University of Mississippi Medical Center
• Original Responsible Party: Leandro Mena, M.D., University of Mississippi Medical Center, Division of Infectious Diseases
• Current Study Sponsor: University of Mississippi Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Mississippi State Department of Health
• University of Alabama at Birmingham

Investigators

• Principal Investigator: Leandro A Mena, MD, MPH; University of Mississippi Medical Center

• PRS Account: University of Mississippi Medical Center
• Verification Date: May 2016